Condition category
Infections and Infestations
Date applied
17/04/2007
Date assigned
31/10/2008
Last edited
19/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Mark Thursz

ORCID ID

Contact details

Hepatology Section
Imperial College St Mary's Campus
Norfolk Place
London
W2 1NY
United Kingdom
+44 (0)20 7594 3851 or 7886 1903
m.thursz@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0701716

Study information

Scientific title

Warfarin Anticoagulation for liver Fibrosis in patients Transplanted for hepatitis C virus infection

Acronym

WAFT-C

Study hypothesis

Anticoagulation reduces the rate of liver fibrosis in patients who have received a liver transplant for hepatitis C related disease.

More details can be found at:
http://www.mrc.ac.uk/ResearchPortfolio/Grant/Record.htm?GrantRef=G0701716&CaseId=11006

Ethics approval

The Royal Free Hospital and Medical School Research Ethics Committee, 20/06/2007, ref: 07/Q0501/79

Study design

Randomised controlled open-label trial (randomisation is stratified by gender and centre)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Liver fibrosis, hepatitis C

Intervention

Warfarin (anticoagulation) for a duration of two years at a dose to maintain the international normalised ratio (INR) at 2 - 3. The warfarin will be taken orally on a daily basis. The control group will receive standard post-transplant care only. The follow-up duration of the trial is the duration of the intervention i.e., two years, after which patients will be followed up as per routine clinical care in their respective liver transplant clinics.

Intervention type

Drug

Phase

Not Applicable

Drug names

Warfarin

Primary outcome measures

Stage of liver fibrosis at end of treatment period (two years).

Secondary outcome measures

1. Number of activated hepatic stellate cells per high power field on liver biopsy
2. Non-invasive measures of liver fibrosis

Overall trial start date

01/07/2007

Overall trial end date

01/07/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Hepatitis C virus (HCV) infection
2. Age greater than 17, either sex
3. Liver transplant within previous 4 months
4. Informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

Participant exclusion criteria

1. Patients requiring anticoagulation for existing clinical indications
2. Standard contraindications to anticoagulation (active peptic ulcer disease, past history of haemorrhagic stroke, thrombocytopaenia (platelets count less than 90 x10^9/L)
3. Large oesophageal varices persisting post-transplant
4. Cerebrovascular abnormalities on pre-transplant computed tomography (CT) scan
5. Human immunodeficiency virus (HIV) antibody positive

Recruitment start date

01/07/2007

Recruitment end date

01/07/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Imperial College St Mary's Campus
London
W2 1NY
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

Clinical Research Office
G02
Sir Alexander Fleming Building
South Kensington
London
SW7 2AZ
United Kingdom

Sponsor type

University/education

Website

http://www3.imperial.ac.uk/

Funders

Funder type

Research organisation

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes